510(k) · Cleared
ClearedEndovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Manufacturing and Research, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 25, 2009 as substantially equivalent to K962375 (Boston Scientific Corp, 1996) and 1 other predicate after a 195-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Jun 25, 2009
- Review
- 195 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901501 (1990). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- 1 generation backK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- This deviceK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
- Descendant · 2 generations on · 1 of its ownK180708 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018
- Descendant · 3 generations on · 0 of its ownK232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023
Most influential descendants
Showing 3 of 3 · See all- K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014 · cites it directly2descendants
- K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018 · 2 generations on1descendant
- K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| −1 | K962375 | Microvasive Balloon Gastrostomy Tube Kit | Boston Scientific Corp | 1996 | — |
| 0 (this device) | K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 | Mri Manufacturing and Research, Inc. | 2009 | — |
| +1 | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2014 | — |
| +2 | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018 | — |
| +3 | K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962375 | Microvasive Balloon Gastrostomy Tube KitSummary page 1…erostomy Classification Name: Tube, Gastro-enterostomy, product code KNT Predicate device: Microvasive Balloon Gastrostomy Tube Kit, K962375 EndoViveTM Low Profile Button Replacement Gastrostomy Tube,… | 1996 |
| * | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement…Summary page 1…oon Gastrostomy Tube Kit, K962375 EndoViveTM Low Profile Button Replacement Gastrostomy Tube, K014297 Reason for submission: Not previously marketed in the USA Device Description and Materials: The EndoViveTM Low Pr… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130674 (Xeridiem Medical Devices, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K962375.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The EndoViveTM Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083685: Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026